Quality Partner, Commercial (EMEA & LATAM)

📋 Description

• • As a pivotal member of the Global Quality and Compliance organization, you will serve as the primary quality and compliance representative within the EMEA & LATAM Commercial leadership team, acting as a crucial bridge between quality functions and regional business operations.
• • This role is instrumental in ensuring QuidelOrtho's "Right to Operate" within the dynamic EMEA & LATAM markets by providing expert technical quality and compliance guidance, proactively addressing quality issues, and driving the continuous improvement of quality systems and processes.
• • You will be a key contributor to maintaining regulatory compliance and enabling the business to adapt with agility and confidence in an ever-evolving global landscape.
• • Your responsibilities will span across all critical quality disciplines, including Quality Operations, Product Care & Technical Quality, Product Health & Monitoring, and Quality Systems Excellence, ensuring a holistic approach to quality management.
• • Through active engagement with Quality Lifecycle teams, you will champion scientific and operational rigor, ensuring adherence to applicable local regulations and driving the harmonization of processes and practices across the entire Global Quality Organization.
• • You will collaborate closely with Regional Commercial Leadership, Business Unit Product Management, Regional Supply Chain, and Regulatory Affairs to elevate quality standards, accelerate innovation, and build unwavering confidence in our products and processes.
• • Act as the regional subject matter expert for Global Quality & Compliance, offering technical and quality leadership and representing the Quality Function within the Commercial Leadership Team, serving as the initial point of contact for quality concerns identified within the region.
• • Foster cross-functional collaboration to embed Quality requirements throughout the entire product lifecycle, from initial design and commercialization through to post-market surveillance, effectively addressing issues that impact the Regional Commercial Team.
• • Leverage data and analytics to meticulously monitor Quality system performance, identify potential risks, and uncover opportunities for the Regional Commercial Team, formulating data-driven recommendations for improvement based on trend analysis and customer feedback.
• • Champion the voice of the customer by engaging with Quality Life Cycle teams, ensuring that Quality processes and decisions prioritize patient safety, regulatory compliance, and business continuity, influencing business-wide prioritization to resolve quality and compliance issues and deliver tangible business and customer value.
• • Provide essential education and guidance to Commercial Teams on Quality System requirements and relevant regulations, tailored to their specific roles, and offer expert advice and enablement for managing quality issues with customers and third-party partners.
• • Offer comprehensive Quality support for the sales process, including the coordination of Tender Support, meticulous completion of customer questionnaires, and conducting customer visits as required.
• • Ensure that all Quality systems, products, processes, and tools strictly adhere to global and regional regulatory requirements, including but not limited to ISO 13485, FDA 21 CFR 820, IVDR, and ANVISA RDC 830/2023.
• • Partner with other functional Quality teams to successfully deploy global procedures, tools, metrics, and process excellence initiatives, ensuring the standardization of Quality processes and documentation across the region to enhance compliance, efficiency, and integration.
• • Actively support inspection readiness and regulatory engagement by contributing technical expertise and ensuring sustained compliance, identifying and assessing quality risks within the region, and collaborating with the Global Quality Team to implement effective mitigation strategies.
• • Provide valuable guidance, coaching, and mentorship to junior Quality professionals, cultivating a strong culture of scientific integrity, quality and compliance management, and a proactive continuous improvement mindset throughout the team.